System and method for managing regulatory information

ABSTRACT

Systems and methods for managing regulatory information. The system comprises a submission controller, a registration controller and a submission archive controller. The submission controller may manage a submission structure, and allow users to search for documents in a content management system and add the documents to the submission structure. The registration controller may manage product registration information and health authority interactions globally, and capture, view and take actions upon product registrations. The submission archive controller may allow users to access a complete history of regulatory submissions and correspondence globally, with an easy to use interface. The three controllers reside in a single system that allows them to interact seamlessly with each other.

CROSS-REFERENCE TO RELATED APPLICATION

The present application is a continuation of U.S. nonprovisional patentapplication Ser. No. 16/708,425, filed on Dec. 9, 2019, entitled Systemand Method for Managing Regulatory Information, which is acontinuation-in-part of U.S. nonprovisional patent application Ser. No.15/494,337, filed on Apr. 21, 2017, entitled System and Method forManaging Regulatory Information. Both applications are herebyincorporated by reference herein for all purposes.

BACKGROUND

The subject technology relates generally to content management systems,and more particularly to managing regulatory information.

Regulatory information management (RIM) has become a major focus amongpharmaceutical companies, since it is important to meet their regulatoryand compliance obligations, and improve their business processes andproductivity across the global. For a pharmaceutical company, theregulatory information may include, e.g., safety reporting, productregistrations, central and local requirements, submissions to healthauthorities, and health authority information management. However,regulatory information is traditionally captured in a multitude ofdisconnected central and local systems, which creates redundancies andduplication of efforts worldwide.

SUMMARY

The disclosed subject matter relates to a system for managing regulatorydocuments. The system comprises a submission controller for generating asubmission user interface which comprises a first area for receiving afirst query for a first document, a second area for receiving a requestfor a submission structure for a first submission, a third area forreceiving a request for a first task, and a fourth area for displaying asearch result in response to the first query. The submission controllermay further: in response to a request for a submission structure,display the submission structure for the first submission, wherein thesubmission structure for the first submission comprises a hierarchy ofdocumentation of the first submission. The submission controller mayfurther: in response to the first query, search a content and datamanagement system for the first document, and display a search result inthe fourth area. The submission controller may further: in response to arequest for adding the first document to the submission structure forthe first submission, add the first document to the submissionstructure.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates an example high level block diagram of a regulatoryinformation management architecture wherein the present invention may beimplemented.

FIG. 2 illustrates an example high level block diagram of a computingdevice.

FIG. 3 illustrates an example high level block diagram of the contentmanagement server according to one embodiment of the present invention.

FIG. 4 illustrates an example submission user interface according to oneembodiment of the present invention.

FIG. 5 illustrates an example task user interface according to oneembodiment of the present invention.

FIG. 6 illustrates an example submission structure user interfaceaccording to one embodiment of the present invention.

FIG. 7 illustrates an example submission structure user interfaceaccording to one embodiment of the present invention.

FIG. 8 illustrates an example dashboard report user interface accordingto one embodiment of the present invention.

FIG. 9 illustrates an example registration user interface according toone embodiment of the present invention.

FIG. 10 illustrates an example registration report user interfaceaccording to one embodiment of the present invention.

FIG. 11 illustrates an example submission archive user interfaceaccording to one embodiment of the present invention.

FIG. 12 illustrates an example submission archive user interfaceaccording to one embodiment of the present invention.

FIGS. 13A and 13B illustrate a flowchart of a method for managingdocument variations in submissions with the regulatory informationmanagement architecture according to one embodiment of the presentinvention.

FIG. 14 illustrates a status report for managing document variations insubmissions with the regulatory information management architectureaccording to one embodiment of the present invention.

DETAILED DESCRIPTION

The detailed description set forth below is intended as a description ofvarious configurations of the subject technology and is not intended torepresent the only configurations in which the subject technology may bepracticed. The appended drawings are incorporated herein and constitutea part of the detailed description. The detailed description includesspecific details for the purpose of providing a thorough understandingof the subject technology. However, the subject technology is notlimited to the specific details set forth herein and may be practicedwithout these specific details. In some instances, well-known structuresand components are shown in block diagram form in order to avoidobscuring the concepts of the subject technology.

FIG. 1 illustrates an example high level block diagram of an enterprisecontent management architecture 100 wherein the present invention may beimplemented. The enterprise may be a business, or an organization. Asshown, the architecture 100 may include a content management system 110,and a plurality of user computing devices 120 a, 120 b, . . . 120 n,coupled to each other via a network 150. The content management system110 may include a content storage system 111 and a content managementserver 112. The content storage system 111 may have one or more contentand data repositories, e.g., 111 a, 111 b, 111 c, and 111 n. The network150 may include one or more types of communication networks, e.g., alocal area network (“LAN”), a wide area network (“WAN”), anintra-network, an inter-network (e.g., the Internet), atelecommunication network, and peer-to-peer networks (e.g., ad hocpeer-to-peer networks), which may be wired or wireless.

The user computing devices 120 a-120 n may be any machine or system thatis used by a user to access the content management system 110 via thenetwork 150, and may be any commercially available computing devicesincluding laptop computers, desktop computers, mobile phones, smartphones, tablet computers, netbooks, and personal digital assistants(PDAs).

The content management server 112 is typically a remote computer systemaccessible over a remote or local network, such as the network 150. Thecontent management server 112 may include a regulatory informationmanagement module 114. The regulatory information management module 114may have a submission controller 1141, a registration controller 1142and a submission archive controller 1143, which will be described indetail with reference to FIG. 3 .

The content storage system 111 may store content that user computingdevices 120 a-120 n may access. Each content repository (e.g., 111 a,111 b, 111 c or 111 n) may store a specific category of content, andallow users to interact with its content in a specific business context.

In one implementation, the repository 111 a may store a submissionslibrary for regulatory content related to submissions, which may includeinformation and submissible documents and data for the generation ofsubmission structures, and the planning, authoring and collection ofrequired documents. Within the submissions library, users may quicklyfind information they are looking for through search and filtering. Theuser may find drug documentation related to a product or a geographicregion. The repository 111 a may also store information about review andapproval flow, status of documents and a filing, and dashboard reports,giving users the ability to manage the overall process.

In one implementation, the repository 111 a may also store regulatoryinformation related to product registration, which may include productregistration information and health authority interactions. The productregistration information may include, e.g., the associated productinformation, application information, application date, registrationdetails, key registration dates, marketing status, and marketingdetails. In one example, the user may see all the global registrationsand their status in one report. The health authority interactions mayinclude bidirectional interactions with health authorities globally,including correspondence, commitments and queries.

In one implementation, the repository 111 a may also store informationfor a submission archive, which may include a customer's complete globalhistory of regulatory submissions and correspondence.

In one implementation, the repository 111 a may also store sourcedocuments for the regulatory information management system.

Although the submissions library, regulatory information related toproduct registration, submission archive, and source documents for theregulatory information management system are shown to be stored in onerepository, it should be understood that they might be stored inmultiple repositories.

In one implementation, the content management system 110 may be amulti-tenant system where various elements of hardware and software maybe shared by one or more customers. For instance, a server maysimultaneously process requests from a plurality of customers, and thecontent storage system 111 may store content for a plurality ofcustomers. In a multi-tenant system, a user is typically associated witha particular customer. In one example, a user could be an employee ofone of a number of pharmaceutical companies which are tenants, orcustomers, of the content management system 110.

In one embodiment, the content management system 110 may run on a cloudcomputing platform. Users can access content on the cloud independentlyby using a virtual machine image, or purchasing access to a servicemaintained by a cloud database provider.

In one embodiment, the content management system 110 may be provided asSoftware as a Service (“SaaS”) to allow users to access the contentmanagement system 110 with a thin client.

FIG. 2 illustrates an example block diagram of a computing device 200which can be used as the user computing devices 120 a-120 n, and thecontent management server 112 in FIG. 1 . The computing device 200 isonly one example of a suitable computing environment and is not intendedto suggest any limitation as to scope of use or functionality. Thecomputing device 200 may include a processing unit 201, a system memory202, an input device 203, an output device 204, a network interface 205and a system bus 206 that couples these components to each other.

The processing unit 201 may be configured to execute computerinstructions that are stored in a computer-readable medium, for example,the system memory 202. The processing unit 201 may be a centralprocessing unit (CPU).

The system memory 202 typically includes a variety of computer readablemedia which may be any available media accessible by the processing unit201. For instance, the system memory 202 may include computer storagemedia in the form of volatile and/or nonvolatile memory such as readonly memory (ROM) and/or random access memory (RAM). By way of example,but not limitation, the system memory 202 may store instructions anddata, e.g., an operating system, program modules, various applicationprograms, and program data.

A user can enter commands and information to the computing device 200through the input device 203. The input device 203 may be, e.g., akeyboard, a touchscreen input device, a touch pad, a mouse, amicrophone, and/or a pen.

The computing device 200 may provide its output via the output device304 which may be, e.g., a monitor or other type of display device, aspeaker, or a printer.

The computing device 200, through the network interface 205, may operatein a networked or distributed environment using logical connections toone or more other computing devices, which may be a personal computer, aserver, a router, a network PC, a peer device, a smart phone, or anyother media consumption or transmission device, and may include any orall of the elements described above. The logical connections may includea network (e.g., the network 150) and/or buses. The network interface205 may be configured to allow the computing device 200 to transmit andreceive data in a network, for example, the network 150. The networkinterface 205 may include one or more network interface cards (NICs).

FIG. 3 illustrates an example high level block diagram of the contentmanagement server 112 according to one embodiment of the presentinvention. The content management server 112 may be implemented by thecomputing device 200, and may have a processing unit 1121, a systemmemory 1122, an input device 1123, an output device 1124, and a networkinterface 1125, coupled to each other via a system bus 1126. Theregulatory information management module 114 may be stored in the systemmemory 1122. The regulatory information management module 114 may have asubmission controller 1141, a registration controller 1142 and asubmission archive controller 1143.

The submission controller 1141 may generate a submission user interface400 for the user to search the submission library. The user may findinformation he is looking for (e.g., a drug documentation related to aproduct) through searching via a search window 401, or filtering viafilters 402. The user may also search for information specific to ageographic region, e.g., by selecting My Local View. The user interface400 may have a window 410 for displaying documents based on the searchresult. In one implementation, submission is based on the druginformation association (“DIA”) reference model, and the reference modelclassification is built based on the latest DIA standards.

When the user clicks on a Task tab 410 on the user interface 400, a taskuser interface 500 may be displayed, and the user may work on his/hertasks, e.g., participating review and approval flow works.

The submission controller 1141 may also manage submission structures(e.g., a New Drug Application (“NDA”) submission structure, or aBiological License Application (“BLA”) submission structure). When theuser clicks on the Submission Structure tab 420 on the user interface400, a submission structure interface 600 may be displayed. One or moresubmission structures may be shown on the submission structure interface600, e.g., an NDA.

If the user selects one of the submission structures, e.g., NDA 8700, auser interface 700 for that submission structure may be displayed, whichmay include the hierarchy of the documentation, e.g., AdministrativeInformation, Common Technical Document Summaries, Quality, NonclinicalStudy Reports, and Clinical Study Reports. The submission structure mayserve as materials for the submission. The submission structure mayinclude placeholder documentation for expected documents, and linkdocuments from repositories in the content storage system 111 directlyinto the submission structure. In one example, the user may want to adda clinical overview from the existing set of documentation. He maysearch for it in the content storage system 111 and drag it to thesubmission structure. The user may also add a link or reference ofcontent from other repositories directly into the structure.

Through the process of structure assembly and management of content, thesubmission controller 1141 may also provide dashboard reports to giveusers the ability to manage the overall process through structureassembly and management of the content. As shown in FIG. 8 , thedashboard report may include current status of the NDA filing, in termsof documentation, a quick look of the status of the documents, eachmajor module, as well as any workflows. From the dashboard, users mayclick into any of the wedges, and be taken to the report results. Fromthe report results, users may take actions on the documents themselves.

The registration controller 1142 may provide a powerful tool for gettingvisibility to global registration information, and take actions onregulatory events. All tied seamlessly with various information andfunctions provided by the content management system 110. Theregistration controller 1142 may manage registration, product andapplication information to help customers to make informed decisionsabout their business. The registration controller 1142 may displayregistration, product and application information on a user interface900. If a user wants to understand the global footprint of a productColdcap, he may click on the Report button on the user interface 900.The user interface 1000 may be presented, displaying globalregistrations and their status in one report. The reports areactionable, allowing users to drill in a specific registration, e.g.,the AU Coldcap 390 registration. The registration record may provide keyinformation including the register information, the associated productinformation, application date, and key registration dates. Theregistration record may be displayed on a separate user interface.Information in the registration record may be based on the IDMP datamodel. The registration controller 1142 may display a user interface forreceiving product registration information and updates. The registrationcontroller 1142 may further provide a comprehensive ability to not onlycapture and view regulatory data, but also take actions when an eventoccurs, including the ability to assess the impact of change, and manageglobal response to such change.

In addition to provide registration information, the registrationcontroller 1142 may allow users to take actions on the regulatorybusiness. Users may initiate an action through an event (e.g., updatethe Coldcap shelf life to 30 months), and assign activities to thatevent. The activities may be acted on by regulatory personnel that areresponsible for a market. Activities may include submission responses.The user can also view the associated submission to address theactivity.

Users may trace an actual submission binder representing the submissiblecontent managed in submission library. User may also see key relatedcontent and data, such as correspondence and commitment made by thebasis for the submission.

The registration controller 1142 may provide powerful, cloud basedcapabilities to manage product registration information and healthauthority interactions globally, and robust abilities to capture, viewand take actions upon product registrations. It may track bidirectionalinteractions with health authorities globally, including correspondence,commitments and queries. With the related data features of the contentmanagement system 110, it may relate actions to be taken to productregistrations. Since it is cloud based, it may tear down the virtualwalls that often exist between centralized regulatory teams and theiraffiliates. Typically, the registration controller 1142 allows users atlocal sites to access and capture data related to their registration,while have visibilities into and collaborate with teams globally.

In one implementation, the registration controller 1142 is based uponthe new Identification of Medicinal Products (“IDMP”) data standard forproduct data, and can support an interface that allows regulatory groupsto standardize their registration data, while also make it easy tointerface with other software applications.

The registration controller 1142 may help to improve data quality, andmake it easy to collaborate with global partners, affiliates andauthorities, while reducing duplication and discrepancies by providing asingle centralized depository for capturing and sharing regulatory data.The registration controller 1142 may also provide robust reporting anddashboard, and make it easy to report on, and visualize key data points,such as marketing status, registration details and marketing details.

The submission archive controller 1143 may provide a powerful, cloudbased capability to access a complete history of regulatory submissionsand correspondence globally, with an easy to use interface. From theupload and view perspective, the submission archive controller 1143 mayprovide electronic common technical document (“eCTD”), non-eCTDelectronic, paper and PDF submissions. With the powerful search andfilter capabilities of the content management system 110, the submissionarchive controller 1143 may make document and data search fast and easy.Upon import, all navigation within and outside of documents is renderedto be fully navigable in the content management system 110, making iteasy to follow references. In addition, there is a built-in viewer. ForeCTDs, it allows users to view submissions in a current view,sequentially, or as cumulative document views.

The submission archive controller 1143 works globally. Given that it iscloud based, it may provide a centralized archive for sharing globalfilings across the enterprise without requiring any additional software.In addition, with its powerful, easy to use searching and filteringcapability, the submission archive makes it easy to find previouslysubmitted information, in order to respond quickly to internal andexternal queries.

The submission archive controller 1143 may assist the process fromsubmission planning to content authoring and publishing, by storing andviewing published output. The submission archive controller 1143 maydisplay user interfaces in FIG. 11 and FIG. 12 for users to search andsee the previously submitted information. As shown in FIG. 11 , userscan navigate to the viewer tab and select the application to view.Through the viewer, the user and navigate to published output, and getinformation on published facts. For a summary document, users can seepublished info from the backbone, and also historical context, as shownin FIG. 12 . Users can view the output the content management system110, and use the native navigation of the document, including bookmarksand cross document hyperlinks.

In previous solutions, published output resides on uncontrolled filedrives, disconnected from the source content. The submission archivecontroller 1143 addresses the need to securely map published outputwhile providing global accessibility by storing the published output andallowing users to access the published output.

In one implementation, the regulatory information management system mayuse the same data model for data objects for submission, productregistration, submission archive, and source document management, andshare data (e.g., product information and manufacturer information)among these functions, so as to avoid duplicate data entry, managementand tracking. Health authorities define data requirements, and theregulatory information management system may provide information aboutthe health authority data requirements. Customers may decide the dataand documents to submit based on the information about the healthauthority data requirements, depending on the type of the submission. Anexample data model for Product is shown below. The bolded names are theobjects in the system, in italics are the actual names of the records.

Product—Cold medicine (this is a generic name)

-   -   Drug Products        -   DP1—Coldcap A (this is the marketed name)        -   Product Details (this is how it's sold. Each one of these            could be manufactured by a different manufacturer, and could            contain different active substances or inactive ingredients)            -   45 mg vial            -   45 mg tablet            -   90 mg vial            -   90 mg tablet        -   DP2—Coldcap B        -   Product Details            -   30 mg capsule            -   60 mg capsule

The system of the present invention unites contributors, partners, andaffiliates in the cloud with a single destination for regulatorydocuments. Global and regional submission dossiers harmonize planningand provide real-time visibility into submission readiness. Globalizingprocesses becomes substantially easier with a single authoritativesource for submissions content. Global alignment may maintain greatercontrol over the distribution and tracking of documents that affiliatessubmit to local authorities. The system may track the progress ofdocuments through actionable reports and dashboards, mitigating risks tosubmission timelines, and enabling continuous visibility of thedocuments. The system may eliminate manual processing to speedsubmission assembly and improve SOP compliance and speed to marketglobally. It may automate tracking and reporting by authoring,exchanging, and assembling documents directly within the contentmanagement system 110.

In practice, a submission may include hundreds of documents, and thereis often reuse in submissions across documents and submissionstructures. Different versions of the documents may be submitted toauthorities in different regions, and they may have different statusesincluding submitted, superseded, approved, rejected and withdrawn. Forexample, version 1 of a particular document is submitted to Norway,version 2 of the document is submitted to the U.S. and is approved, andversion 3 of the document is submitted to Malaysia and is rejected.There are usually multiple changes and multiple submissions in productreports, in regions, both at the submission level and individualdocument level. It is often difficult to see the statuses of thedocuments across the regions. Thus, it is desirable to provide a methodand system to help the pharmaceutical companies to find out thesubmitted documents, their versions and statuses in each region.

The system and method of the present invention may collect submissiondata of documents in all markets/regions in one system and report on thecontext of use. Documents may be tagged with metadata that defines thescope of use, e.g., product and product substance. Submission contentmay be organized into a submission structure for planning and tracking.Submission content may be matched to submission structure automaticallybased on metadata to allow for re-use of the submission contentregardless of the submission format. The submission structure may belinked to regulatory objective information. Registration data may trackstatus of regulatory objectives in each market/region. Reporting acrossall entities may bring together a view of currently approved content inall markets.

A number of types of documents and data may be involved in thesubmission. Source documents, the documents being written and authored(e.g., a Word document), can be general documents shared across theregion which describe the product as a whole. Regional content could becontent that is specific to a region (e.g., Europe). Published outputmay include the actual published output after the submission is formedand authored when all documents meet authority requirements and areready to be published. Registration data may include data about aregistration including related products actually licensed for use inthat particular country.

FIGS. 13A and 13B illustrate a flowchart of a method for managingdocument variations in submissions with the regulatory informationmanagement architecture according to one embodiment of the presentinvention. The process may start at 1301.

At 1303, a source document D1 may be stored to the repository 111 a. Thesource document may be drafted in the architecture 100 (e.g., with theuser computing device 120 b), or drafted in another system and uploadedto the architecture 100. Some metadata may be collected and storedtogether with the source document D1, and may include the product, theversion of the document and its submission status (e.g., not-submitted).In one example, the source document may be tagged with metadata thatdefine the scope of use, e.g., the product substance. Other metadata maybe included, depending on the type of document. It could also berelated, for example, to a particular clinical study, active substanceor a form strength of the product.

At 1305, the source document D1 may be updated to D2, and stored to therepository 111 a. Metadata may be stored together with the document D2,and may include the product, the version of the document and itssubmission status (e.g., not-submitted).

At 1307, a user input for selecting a submission structure for a firstregion may be received at the submission controller 1141, and thesubmission structure for the first region may be selected in response.In one example, the submission structure may be linked to regulatoryobjective.

At 1309, the source document D1 may be added to the selected submissionstructure for the first region. The source document D1 may be added bybeing dragged to the selected submission structure for the first regionby a user, by being linked from the content storage system 111 to theselected submission structure for the first region, or by beingautomatically matched to the selected submission structure for the firstregion based on the metadata of the source document D1 and that of thesubmission structure for the first region. In one example, the sourcedocument D1 may be automatically matched to the submission structure forthe first region based on the product name in the metadata of the sourcedocument D1 and the metadata of the submission structure for the firstregion by the submission controller 1141.

In one embodiment, the ties between the documents may be built upthrough a content plan. The content plan may automatically match thecontent to the submission structure based metadata. The metadata can be,e.g., the type of documents, the product, and the product substances.Multiple different attributes may be used to match the documents to anew submission.

Each submission may have its own content plan, and each content plan mayhave documents automatically matched to it. The content plan may have anumber of content plan items and each content plan item may representthe metadata about the context of use of the document within theparticular submission. A matched document may be located by checkingcontent plan items against the representation of the document in thestructure.

In one embodiment, the document may be matched to a content plan basedon certain matching fields, certain attributes that exist on thedocument details and also exist on the content plan. The submissioncontroller 1141 may check the matching fields and tries to match thedocument to the content plan, e.g., based on type, sub-type,classification of the document, submission and application.

At 1311, when the submission for the first region is submitted, themetadata of the document D1 in the submission for the first region maybe updated. In addition to the product and the version of the document,the metadata may also include the first region, date of the submission,and the user who submitted the submission, active substance, clinicalstudy, application or any other data element relevant to this particulartype of document. Subsequently, its submission status may be changed tosubmitted.

Registration is the approval to sell a product in a particular market orregion. Registration may come after multiple submissions when regulatoryobjectives are met. Some submissions may have hundreds of documents forthe purpose of registering one product in a particular market/region. Asubmission is market specific, but documents are not necessarily marketspecific, and could be reused across multiple submissions. Registrationdata may track status of the regulatory objective in each region, ifthey are approved, rejected, or withdraw. Registration data may includeinformation about the registration, e.g., registration name, country,status of approval, and license information.

The status of the document D1 may change over the lifecycle of thesubmission, e.g., from submitted, to rejected, superseded, withdraw andapproved. The submission controller 1141 may continuously track thestatus of the source document D1 through the lifecycle of the submissionat 1313.

At 1321, a user input for selecting a submission structure for a secondregion may be received at the submission controller 1141, and thesubmission structure for the second region may be selected in response.

At 1323, the document D2 may be added to the selected submissionstructure for the second region. The source document D2 may be added bybeing dragged to the selected submission structure for the second regionby a user, by being linked from the content storage system 111 to theselected submission structure for the second region, or by beingautomatically matched to the selected submission structure for thesecond region based on the metadata of the document D2 and that of thesubmission structure for the second region.

At 1325, when the submission for the second region is submitted, themetadata of the document D2 in the submission for the second region maybe updated. In addition to the product and the version of the document,the metadata may also include the second region, date of the submissionto the second region, and the user who submitted the submission, and itssubmission status may be changed to submitted.

The status of the document D2 and other documents in the submission maychange over the lifecycle of the submission, e.g., from submitted, torejected, superseded, withdraw and approved. The submission controller1141 may continuously track the statuses of the document D2 and otherdocuments in the submission through the lifecycle of the submission at1327.

The user may want to check the overall status of the submission, and thestatus of a specific document in the context of that submission. At1331, a user input for checking status of a target document, e.g., thedocument D2, may be received.

At 1333, the submission controller 1141 may check metadata of thedocument D2, metadata of all version of the document D2, including itsolder versions (e.g., D1) and newer versions, and metadata of thesubmissions including each version of the document D2, including thesubmission for the first region, and the submission for the secondregion.

At 1335, a report of statuses of all versions of the target document maybe generated based on the metadata of all versions of the targetdocument and the submissions including each version of the targetdocument. As shown in FIG. 14 , the report may have the status of eachversion of the target document, including different statuses of it basedon the market/region and the submission that it is in. The report mayshow the relationships between different documents based on metadata toprovide users the context of views of documents with a particular marketand a particular time. Specifically, the submission in the first rowused version 2.0, the initial MAA (Marketing Authorization Application,the main type of application in the EU), which is superseded. Itssubmission is approved and its registration in European Union is alsoapproved. The submission in the second row used version 3.0, the updatedspecification, which is superseded. Its submission is approved and itsregistration in European Union is also approved. The submission in thethird row used version 4.0, the updated specification, which issuperseded. Its submission is approved and its registration in EuropeanUnion is also approved. All the rows are based on the same sourcedocument, and the user can see the statues of all its versions and thestatues of the submissions including each version.

The above-described features and applications can be implemented assoftware processes that are specified as a set of instructions recordedon a computer readable storage medium (also referred to as computerreadable medium). When these instructions are executed by one or moreprocessing unit(s) (e.g., one or more processors, cores of processors,or other processing units), they cause the processing unit(s) to performthe actions indicated in the instructions. Examples of computer readablemedia include, but are not limited to, CD-ROMs, flash drives, RAM chips,hard drives, EPROMs, etc. The computer readable media does not includecarrier waves and electronic signals passing wirelessly or over wiredconnections.

These functions described above can be implemented in digital electroniccircuitry, in computer software, firmware or hardware. The techniquescan be implemented using one or more computer program products.Programmable processors and computers can be included in or packaged asmobile devices. The processes and logic flows can be performed by one ormore programmable processors and by one or more programmable logiccircuitry. General and special purpose computing devices and storagedevices can be interconnected through communication networks.

In this specification, the term “software” is meant to include firmwareresiding in read-only memory or applications stored in magnetic storage,which can be read into memory for processing by a processor. Also, insome implementations, multiple software technologies can be implementedas sub-parts of a larger program while remaining distinct softwaretechnologies. In some implementations, multiple software technologiescan also be implemented as separate programs. Finally, any combinationof separate programs that together implement a software technologydescribed here is within the scope of the subject technology. In someimplementations, the software programs, when installed to operate on oneor more electronic systems, define one or more specific machineimplementations that execute and perform the operations of the softwareprograms. Examples of computer programs or computer code include machinecode, for example is produced by a compiler, and files includinghigher-level code that are executed by a computer, an electroniccomponent, or a microprocessor using an interpreter.

A computer program (also known as a program, software, softwareapplication, script, or code) can be written in any form of programminglanguage, including compiled or interpreted languages, declarative orprocedural languages, and it can be deployed in any form, including as astand alone program or as a module, component, subroutine, object, orother unit suitable for use in a computing environment. A computerprogram may, but need not, correspond to a file in a file system. Aprogram can be stored in a portion of a file that holds other programsor data (e.g., one or more scripts stored in a markup languagedocument), in a single file dedicated to the program in question, or inmultiple coordinated files (e.g., files that store one or more modules,sub programs, or portions of code). A computer program can be deployedto be executed on one computer or on multiple computers that are locatedat one site or distributed across multiple sites and interconnected by acommunication network.

As used in this specification and any claims of this application, theterms “computer”, “server”, “processor”, and “memory” all refer toelectronic or other technological devices. These terms exclude people orgroups of people. For the purposes of the specification, the termsdisplay or displaying means displaying on an electronic device. As usedin this specification and any claims of this application, the terms“computer readable medium” and “computer readable media” are entirelyrestricted to tangible, physical objects that store information in aform that is readable by a computer. These terms exclude any wirelesssignals, wired download signals, and any other ephemeral signals.

It is understood that any specific order or hierarchy of steps in theprocesses disclosed is an illustration of example approaches. Based upondesign preferences, it is understood that the specific order orhierarchy of steps in the processes may be rearranged, or that allillustrated steps be performed. For example, a submission structure maybe selected before documents are stored. Some of the steps may beperformed simultaneously. For example, in certain circumstances,multitasking and parallel processing may be advantageous. Moreover, theseparation of various system components illustrated above should not beunderstood as requiring such separation, and it should be understoodthat the described program components and systems can generally beintegrated together in a single software product or packaged intomultiple software products.

Various modifications to these aspects will be readily apparent, and thegeneric principles defined herein may be applied to other aspects. Thus,the claims are not intended to be limited to the aspects shown herein,but is to be accorded the full scope consistent with the languageclaims, where reference to an element in the singular is not intended tomean “one and only one” unless specifically so stated, but rather “oneor more.” Unless specifically stated otherwise, the term “some” refersto one or more.

What is claimed is:
 1. A system for managing regulatory information,comprising: a content storage system comprising a plurality ofrepositories for storing content and data; and a content managementserver, coupled to the content storage system and comprising asubmission controller for: generating a submission user interface whichcomprising a first area for receiving a first query for a firstdocument; a second area for receiving a request for a submissionstructure for a first submission, a third area for receiving a requestfor a first task, and a fourth area for displaying a search result inresponse to the first query; in response to the request for thesubmission structure for the first submission, displaying the submissionstructure for the first submission, wherein the submission structure forthe first submission comprises a hierarchy of documentation of the firstsubmission; in response to the first query, searching a content and datamanagement system for the first document, and displaying a search resultin the fourth area; and in response to a request for adding the firstdocument to the submission structure for the first submission, addingthe first document to the submission structure.
 2. The system of claim1, wherein the submission controller further: in response to a secondquery, searches the content and data management system for a seconddocument, obtains a link pointing to the second document in the contentand data management system, and adds the link to a place for the seconddocument in the submission structure for the first submission.
 3. Thesystem of claim 1, wherein the submission structure for the firstsubmission further comprises: a placeholder for a third document.
 4. Thesystem of claim 3, wherein the submission controller further: inresponse to a third query, searches the content and data managementsystem for a third document; displays the third document in the fourtharea, and adds the third document to the placeholder in the submissionstructure for the first submission.
 5. The system of claim 1, whereinthe submission controller further: searches the content managementsystem for a fifth document based on a selected filter.
 6. A system formanaging regulatory information, comprising: a content storage systemcomprising a plurality of repositories for storing content and data; anda content management server, coupled to the content storage system andcomprising a submission controller for: generating a submission userinterface which comprising a first area for receiving a first query fora first document; a second area for receiving a request for a submissionstructure for a first submission, a third area for receiving a requestfor a first task, and a fourth area for displaying a search result inresponse to the first query; in response to the request for thesubmission structure for the first submission, displaying the submissionstructure for the first submission, wherein the submission structure forthe first submission comprises a hierarchy of documentation of the firstsubmission; in response to the first query, searching a content and datamanagement system for the first document, and displaying a search resultin the fourth area; in response to a request for adding the firstdocument to the submission structure for the first submission, addingthe first document to the submission structure; and generating a taskinterface in response to a request, wherein the task interface comprisesa task in progress.
 7. A system for managing regulatory information,comprising: a content storage system comprising a plurality ofrepositories for storing content and data; and a content managementserver, coupled to the content storage system and comprising asubmission controller for: generating a submission user interface whichcomprising a first area for receiving a first query for a firstdocument; a second area for receiving a request for a submissionstructure for a first submission, a third area for receiving a requestfor a first task, and a fourth area for displaying a search result inresponse to the first query; in response to the request for thesubmission structure for the first submission, displaying the submissionstructure for the first submission, wherein the submission structure forthe first submission comprises a hierarchy of documentation of the firstsubmission; in response to the first query, searching a content and datamanagement system for the first document, and displaying a search resultin the fourth area; in response to a request for adding the firstdocument to the submission structure for the first submission, addingthe first document to the submission structure; and generating adashboard user interface in response to a request, wherein the dashboarduser interface comprises a status of a task.
 8. A system for managingregulatory information, comprising: a content storage system comprisinga plurality of repositories for storing content and data; and a contentmanagement server, coupled to the content storage system and comprisinga submission controller for: generating a submission user interfacewhich comprising a first area for receiving a first query for a firstdocument; a second area for receiving a request for a submissionstructure for a first submission, a third area for receiving a requestfor a first task, and a fourth area for displaying a search result inresponse to the first query; in response to the request for thesubmission structure for the first submission, displaying the submissionstructure for the first submission, wherein the submission structure forthe first submission comprises a hierarchy of documentation of the firstsubmission; in response to the first query, searching a content and datamanagement system for the first document, and displaying a search resultin the fourth area; and in response to a request for adding the firstdocument to the submission structure for the first submission, addingthe first document to the submission structure; and a registrationcontroller for displaying a user interface for receiving productregistration information.
 9. The system of claim 8, wherein theregistration controller further: displays a registration user interfacewhich comprises an area for receiving a request for a report; anddisplays a report user interface in response to the request for thereport, wherein the report use interface comprises a first productregistration and its status.
 10. The system of claim 8, wherein theregistration controller further: displays a registration record whichprovides product information, and key registration dates.
 11. The systemof claim 8, wherein the registration controller further: tracksbidirectional interactions with a health authority.
 12. The system ofclaim 8, wherein the registration controller further: relates actions tobe taken to a product registration based on data in the content andmanagement system.
 13. The system of claim 8, further comprising: asubmission archive controller for displaying a submission archive userinterface to enable access to previously submitted information.
 14. Thesystem of claim 13, wherein the submission archive user interfacefurther enables access to correspondence related to the submission. 15.The system of claim 1, further comprising: a submission archivecontroller for displaying a submission archive user interface to enableaccess to previously submitted information and correspondence related tothe submission.
 16. A method for managing regulatory information in acontent and data management system, wherein the content and datamanagement system comprises a content storage system comprising aplurality of repositories for storing content and data, and a contentmanagement server coupled to the content storage system and comprising asubmission controller, the method comprising: generating a submissionuser interface which comprising a first area for receiving a first queryfor a first document; a second area for receiving a request for asubmission structure for a first submission, a third area for receivinga request for a first task, and a fourth area for displaying a searchresult in response to the first query; in response to the request forthe submission structure for the first submission, displaying thesubmission structure for the first submission, wherein the submissionstructure for the first submission comprises a hierarchy ofdocumentation of the first submission; in response to the first query,searching the content and data management system for the first document,and displaying a search result in the fourth area; in response to arequest for adding the first document to the submission structure forthe first submission, adding the first document to the submissionstructure; storing a first version of a first source document andmetadata of the first version of the first source document; storing asecond version of the first source document and metadata of the secondversion of first source document; submitting the first version of thefirst source document for a first region; and updating the metadata ofthe first version of the first source document when the first version ofthe first source document for the first region is submitted.
 17. Themethod of claim 16, further comprising: submitting the second version ofthe first source document for a second region; and updating the metadataof the second version of the first source document when the secondversion of the first source document for the second region is submitted.18. The method of claim 17, further comprising: checking metadata of thefirst version of the first source document and metadata of the secondversion of the first source document.
 19. The method of claim 18,further comprising: checking metadata of the submission for the firstregion and metadata of the submission for the second region.
 20. Themethod of claim 19, further comprising: generating a report of the firstsource document based on: metadata of the first version of the firstsource document, metadata of the second version of the first sourcedocument, metadata of the submission for the first region, and metadatafor the submission of the second region.